Sensory Profile and Early Clinical Signs of Calm Room Users

NCT ID: NCT06839950

Last Updated: 2025-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-19

Study Completion Date

2028-05-19

Brief Summary

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This descriptive study aims primarily to characterize the sensory profile of patients in a closed psychiatric hospital unit who use a calming room.

The main questions it aims to answer are :

* Could sensory information processing disorders be the cause of distress and tension in these patients?
* Could users of the calming room present extreme sensory processing profiles, characterized by either hypersensitivity or hyposensitivity ?

Participants will answer a survey to determine their the sensory profile. Participants can already use the calming room as part of their regular medical care and they will answer surveys before and after each use.

Detailed Description

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Conditions

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Psychotic Disorders Personality Disorders Mood Disorders

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Calm room

The calm room combines the effects of music, light, and videos designed with natural atmospheres. Four themes are offered in the calm room: Comfort, Optimism, Freshness, and Lullaby. These themes feature nature videos, combining relaxing images with calm musical ambiance. The lighting can be adjusted by the user, who can choose from a varied color palette. The available lights have a low glare level, and the light intensity can also be adjusted by the user.

They can be used by patients any time they want and for as long as they want.

Intervention Type OTHER

Other Intervention Names

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Sensory room Comfort room

Eligibility Criteria

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Inclusion Criteria

* Gender and Age: Male or female, aged 18 to 65
* Hospitalization: Admitted to the closed hospitalization unit for less than 10 days
* Social security: Affiliated or beneficiary of a social security system
* Consent: Free, informed, and written consent, signed by the participant and/or their legal representative (for participants under protection measures) and the investigator (at the latest on the day of inclusion and before any research-related examination).

Exclusion Criteria

* Inability to understand information related to the study
* Proven sensory disability
* Dementia
* Pregnancy
* Lack of social protection
* Previous Participation in this research protocol (in the case of a new hospitalization)
* Expression abilities incompatible with completing the AASP Scale (e.g., french language comprehension issues, mute individuals, patients in restraint and/or therapeutic isolation)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Esquirol

OTHER

Sponsor Role lead

Responsible Party

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Aude Paquet

Psychomotor Therapist, Doctor in Psychology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Esquirol Hsopital Center

Limoges, Nouvelle-Aquitaine, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Aude Paquet, PhD in Psychology

Role: CONTACT

+33 5-55-43-11-27

Facility Contacts

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Théodore Vinais, Master degree

Role: primary

+33 + 5-87-50-91-29

Aude Paquet, PhD in Psychology

Role: backup

Other Identifiers

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2023-A00580-45

Identifier Type: REGISTRY

Identifier Source: secondary_id

EVAL-APAISE

Identifier Type: -

Identifier Source: org_study_id

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